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Wednesday, August 04, 2021

Russia Covid-19 vaccine: Country to begin late-stage Sputnik V trials on 40,000 people next week

Russia Covid-19 vaccine: Sputnik V has not gone through advanced trials normally required to prove that it works before being licensed, a violation of scientific protocol. 

By: Express Web Desk | New Delhi |
Updated: August 20, 2020 8:46:57 pm
Russia seeks India help for Sputnik Phase 3 trials, manufactureRussia's second request is to hold larger Phase 3 trials in India. (AP Photo)

Mass testing of Sputnik V, Russia’s first potential vaccine for Covid-19, start next week involving more than 40,000 people, Reuters reported. The advanced trial for the vaccine to get domestic regulatory approval, will be overseen by a foreign research body, backers of the project said on Thursday.

These were the first details on the upcoming late-stage trial of the vaccine released by its developers, who are aiming to allay concerns raised by some scientists about the lack of data provided by Russia so far.

Even as Russia claimed to have approved the world’s first coronavirus vaccine, the vaccine, dubbed as Sputnik V, hasn’t gone through advanced trials normally required to prove that it works before being licensed, a violation of scientific protocol. Russian officials claimed the vaccine would provide lasting immunity to the viral infection yet have offered no proof yet.

Health officials and world leaders have criticised Russia for releasing the vaccine in haste, by rushing through the first two phases of clinical trials. Responding to Putin’s claim, a spokesperson for the World Health Organisation (WHO) had said a few weeks back that “rigorous review” and assessment of the vaccine was needed before the global health body could recommend the use of the Russian vaccine, AFP reported.

Here are the latest developments so far:

Want to take time to get full info about the vaccine: Europe’s WHO office

The World Health Organization’s Europe office Thursday said it is trying to obtain more information on the experimental Covid-19 vaccine Russia recently approved and has begun “direct discussions” with the country regarding this, AP reported.

Catherine Smallwood, a senior emergency official at WHO Europe said the agency had begun “direct discussions” with Russia and that WHO officials have been sharing “the various steps and information that’s going to be required for WHO to take assessments”.

Acknowledging that Russia holds a long history of developing and administering vaccines, including those for yellow fever and polio, WHO’s Europe director Dr Hans Kluge said that every vaccine must go through the same clinical trials. Russia’s vaccine has so far only been tested on a few dozen people.

“This concern that we have around safety and efficacy is not specifically for the Russia vaccine, it’s for all of the vaccines under development,” news agency AP quoted Smallwood as saying. She said WHO was taking an “accelerated approach” to try to speed development of coronavirus vaccines but said “it’s essential we don’t cut corners in safety or efficacy… We’re not going through a rushed job of trying to jump to conclusions here,” Smallwood said. “We want to take our time to really understand where the vaccine’s at and to get as full information as possible on the steps that have already been taken,” she added.

Indian Embassy in Moscow in touch with developer of vaccine

The Indian embassy in Moscow is in touch with the Russian medical research institute that has developed the world’s first Covid-19 vaccine to be cleared for use by the public, top government sources told The Indian Express.

“The Indian Mission is engaging separately with the Russian side through our embassy in Moscow. We are now awaiting the safety and efficacy data of this vaccine for Covid-19,” a source said.

Western experts have been skeptical about the Russian claim, given the speed and secrecy with which the Gamaleya candidate has been given regulatory approval. Developing a vaccine is a complex and lengthy process, and the candidate must pass extensive field trials before it is cleared for human use. The Sputnik V candidate has been approved without being put through final phase 3 human trials.

Read: Why the Russian vaccine is a long way from being available in India

Mexico exploring phase 3 trials of Russian coronavirus vaccine

In an effort secure early supplies of an effective drug to treat the viral infection, Mexico told Moscow Wednesday it would like to carry out Phase 3 of testing Russia’s Covid-19 vaccine. After a meeting with Russia’s ambassador to Mexico, Viktor Koronelli, Foreign Minister Marcelo Ebrard took to Twitter saying he had expressed interest in carrying out large scale human trials “to have the vaccine as soon as possible in Mexico.”

Earlier this week, Mexican President Andres Manuel Lopez Obrador said he would volunteer to be among the first people to try the Russian vaccine if it proved effective. Mexico has also agreed to help manufacture another vaccine candidate being developed by Britain’s AstraZeneca and Oxford University to supply the Latin American market.

Read: Russia’s race for Covid-19 vaccine raises concerns in the West 

Philippines, Serbia ready to take trials

While several leaders and scientists have criticised Putin for releasing the vaccine without adequately testing it first, others, like the Philippines President Rodrigo Duterte, said they are ready to work with Russia to purchase the vaccine.

The Philippines President went as far as volunteering to be injected with vaccine himself in order to alleviate fears. “I will tell President (Vladimir) Putin that I have huge trust in your studies in combating COVID and I believe that the vaccine that you have produced is really good for humanity,” he said in a public address earlier this week. “I can be the first they can experiment on.”

The presidential spokesman said Harry Roque Philippines plans to launch clinical trials for a Russian coronavirus vaccine in October, with President Rodrigo Duterte expected to be inoculated as early as May next year,

Serbian President Aleksandar Vucic joined Duterte to praise Russia for developing an ‘effective’ vaccine so quickly. He, too, said that he would be happy to be the first person to be injected with the vaccine, as long as it is given a green signal by Serbian scientists.

“Our specialists must just confirm to us that it is safe and reliable. It is important that the vaccine appears as soon as possible because it will save our economy,” he told reporters during a press briefing.

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